FDA 510(k) Application Details - K022680

Device Classification Name	System, Test, Human Chorionic Gonadotropin   More FDA Info for this Device
510(K) Number	K022680
Device Name	System, Test, Human Chorionic Gonadotropin
Applicant	AZOG, INC. 1011 US HWY 22 PHILLIPSBURG, NJ 08865 US Other 510(k) Applications for this Company
Contact	AZUBUIKE OGALA Other 510(k) Applications for this Contact
Regulation Number	862.1155   More FDA Info for this Regulation Number
Classification Product Code	DHA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/12/2002
Decision Date	11/01/2002
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review